Chronic Diabetic Foot Ulcer of Right Foot, Chronic Diabetic Ulcer of Left Foot (Diagnosis), Diabetic Foot, Neuropathic Foot Ulcer
Conditions
Brief summary
A randomized, controlled open-label, parallel group study to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil for the healing of non-infected diabetic foot ulcers.
Detailed description
This is a randomized, controlled open-label, parallel group study of 12 weeks duration aimed to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil (S26E) for the healing of non-infected chronic (\>12 weeks) diabetic foot ulcers. The S26E is a natural extract rich in unsaturated (such as linoleic, oleic, palmitic and static) fatty acids which have shown promise in the promotion of wound healing by modulating the migration and functional properties of inflammatory cells in wound cites as well as the production of inflammatory cytokines. The safety of topical S26E application on human skin has been clinically demonstrated. Eligible participants will be adults patients with diabetes mellitus (DM) type 1 or 2 and chronic (persistent for \>12 weeks after initial presentation) neuropathic or neuroischaemic non-infected diabetic foot ulcers. Following recruitment and randomization (on a 1:1 ratio) eligible patients will attend the study site on weekly intervals. After a run-in period of 2 weeks (visits 1-2) during which all participants will receive the optimal standard-of-care for neuropathic/neuroischaemic diabetic ulcers (incl. optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing) eligibility will be reassessed. Participants who will continue in the study will receive standard of care (control group) or standard of care plus daily local S26E application on ulcer (intervention group) (visits 3-12). After visit 12 the application of S26E will be terminated and all participants will receive an additional follow up visit 4 weeks later (final visit). Efficacy end-points will be assessed at the end of the of 12 weeks of observation (Visit 12)
Interventions
OTHERStandard-of-care for neuropathic/neuroischemic diabetic foot ulcers
Optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing
DRUGS26E
Daily application of S26E extract on wound site
Sponsors
National and Kapodistrian University of Athens
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 Diabetes Mellitus * Body Mass Index \<40 kg/m2 * Glycated Hemoglobin (HbA1c) \<10% * Presence of a diabetic foot ulcer with the following features i) Owing to chronic peripheral sensorimotor diabetic neuropathy, with or without peripheral arterial disease (critical ischemia excluded as indexed by an Ankle-Brachial index \<0.4 ) ii) Persistence for \>12 weeks iii) Already following an adequate off-loading method
Exclusion criteria
* Presence of clinical signs of infection * Inability or refusal to follow off-loading methods * Ulcer surface area decline by \>15% during the run-in period * Malignant disease (non-melanoma skin malignancy and healed thyroid malignancies excluded) * Acute Charcot arthropathy * Serious chronic Hepatic (Child-Pugh B or C), Renal (stage 4-5 CKD) or Heart (NYHA 3-4) disease * Known hypersensitivity to the product or its contents * Any random glucose measurement \>350 mg/dl during the run-in period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of ulcer surface area | 12 weeks after enrollment in the study | % change of ulcer surface area |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of completely healed ulcers | 12 weeks after enrollment in the study | Percentage of participants to achieve ulcer healing within the observation period |
| Incidence of adverse events | 12 weeks after enrollment in the study | Incidence of product-related adverse events (local or systemic infection, local hypersensitivity reactions) |
| Incidence of amputations | 12 weeks after enrollment in the study | Number of patients that required an amputation |
Countries
Greece
Outcome results
None listed